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NCT01865149 Clinical Trial

Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus

Hydrocephalus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01865149
Other study ID # 1-2013-0022
Secondary ID
Status Recruiting
Phase N/A
First received May 22, 2013
Last updated May 26, 2013
Start date May 2013
Est. completion date May 2014

Study information
Verified date May 2013
Source Yonsei University
Contact Hyunzu Kim, MD
Phone 82-2-2228-2422
Email aneshyunzu@yuhs.ac
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.

Recruitment information / eligibility
Status Recruiting
Enrollment 38
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 19 Years
Eligibility Inclusion Criteria:

1. ASA ?-?

2. aged between 1 and 19 year

3. hydrocephalus

4. general anesthesia for undergoing drainage of cerebrospinal fluid

Exclusion Criteria:

1. an anatomical or functional abnormality in optic nerve

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• retrobulbar ultrasound
both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary both optic nerve sheath diameter (the posterior 3mm of the papilla) For day 1 from induction of general anesthesia to average 15 min after recovery of general anesthesia No
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